NCT06336447

Brief Summary

This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain. The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jan 2024Feb 2027

Study Start

First participant enrolled

January 12, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

March 21, 2024

Last Update Submit

March 21, 2024

Conditions

Pain, Chronic

Keywords

PainKnee PainVirtual RealityRadio Frequency AblationGenicular Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Procedural related pain

    Reported procedural related pain on a 0-10 verbal rating scale (VRS)

    10 minutes after procedure

Secondary Outcomes (5)

  • Procedure related satisfaction

    10 minutes after prodedure

  • Post procedure anxiety

    10 minutes after procedure

  • Mean reduction in pain 1 month after procedure

    30 days after procedure

  • Midazolam administered

    10 minutes before procedure to end of prodedure

  • Fentanyl administered

    10 minutes before procedure to end of prodedure

Study Arms (2)

Group #1: Virtual Reality Headset

EXPERIMENTAL

Group 1 will be assigned to the Virtual Realtity Headset. Participants will wear the headset for at least 10 minutes prior to the planned procedure. Subjects will receive standard procedure. The VR Headset will be removed 10 minutes after the planned procedure.

Other: Experimental: Group #1: Virtual Reality Headset

Group 2 No Virtual Reality Headset

ACTIVE COMPARATOR

Group 2 will receive standard care without the use of the Virtuality Reality Headset.

Other: Group 2 No Virtual Reality Headset

Interventions

Experimental: Group #1: Virtual Reality HeadsetOTHER

Group 1 will be assigned to the Virtual Realtity Headset. Participants will wear the device for at least 10 minutes prior to the planned procedure. Subjects will receive standard procedure. The VR Headset will be removed 10 minutes after the planned procedure.

Group #1: Virtual Reality Headset
Group 2 No Virtual Reality HeadsetOTHER

Group 2 will receive standard care without the use of the Virtuality Reality Heaset.

Group 2 No Virtual Reality Headset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with knee pain, baseline average of \> 4/10
  • X-ray evidence of osteoarthritis of the knee
  • Pain duration of \>6 weeks and no previous knee surgeries
  • Patients will also only be included who have never undergone a RFA on the affected knee

You may not qualify if:

  • Individuals who do not have evidence of osteoarthritis on X-ray,
  • Secondary gain expected to influence treatment outcomes
  • Poorly controlled psychiatric condition that could affect outcome (e.g. active substance abuse) or impose a barrier to participation
  • Chronic opioid use and anticoagulation therapy that cannot be stopped and could warrant a different treatment approach (e.g. phenol ablation)
  • Severe motion sickness
  • Seizure disorder
  • Vision loss
  • Pregnant
  • Nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine Pain Center

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (7)

  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.

    PMID: 24553908BACKGROUND

  • Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/

    PMID: 29939661BACKGROUND

  • Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.

    PMID: 34308957BACKGROUND

  • Iannaccone F, Dixon S, Kaufman A. A Review of Long-Term Pain Relief after Genicular Nerve Radiofrequency Ablation in Chronic Knee Osteoarthritis. Pain Physician. 2017 Mar;20(3):E437-E444.

    PMID: 28339444BACKGROUND

  • Hoffman HG, Richards TL, Van Oostrom T, Coda BA, Jensen MP, Blough DK, Sharar SR. The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments. Anesth Analg. 2007 Dec;105(6):1776-83, table of contents. doi: 10.1213/01.ane.0000270205.45146.db.

    PMID: 18042882BACKGROUND

  • Ding J, He Y, Chen L, Zhu B, Cai Q, Chen K, Liu G. Virtual reality distraction decreases pain during daily dressing changes following haemorrhoid surgery. J Int Med Res. 2019 Sep;47(9):4380-4388. doi: 10.1177/0300060519857862. Epub 2019 Jul 25.

    PMID: 31342823BACKGROUND

  • Bair MJ, Wu J, Damush TM, Sutherland JM, Kroenke K. Association of depression and anxiety alone and in combination with chronic musculoskeletal pain in primary care patients. Psychosom Med. 2008 Oct;70(8):890-7. doi: 10.1097/PSY.0b013e318185c510. Epub 2008 Sep 16.

    PMID: 18799425BACKGROUND

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jason Ross, MD

    Northwestern Univesity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Fitzgerald, RN,BSN,MS

CONTACT

312-695-1064p-fitzgerald2@northwestern.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded to study randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trail.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 28, 2024

Study Start

January 12, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

March 28, 2024

Record last verified: 2024-03

Locations

US(1)